Innovation or Exploitation?”Patent Trolls” and their Application to Biotechnology

Credit: Quincy Bulin, Woman’s World

I. Introduction

The United States patent system has a foundational bargain: in exchange for publicly disclosing a certain invention, the inventor receives a limited monopoly to exclude others from making, using, or selling that invention. This framework, which is codified in Article I Section 8 of the Constitution and implemented through federal patent statutes, is designed to incentivize innovation by ensuring inventors can recoup their research and development investments.

This incentive structure is critical to biotechnology, where the pipeline for bringing a single therapeutic from laboratory concept to FDA-approved product can regularly require over a decade of research and billions of dollars in capital. In essence, the exclusive rights granted by patents theoretically allow biotech firms to justify these investments by securing a period of market exclusivity for their development.

Yet the patent system’s original promise of fostering innovation is increasingly colliding with a phenomenon that has attracted criticism from policymakers, industry stakeholders, and legal scholars: the rise of patent assertion entities, often referred to as PAEs or, even more casually, “patent trolls.” PAEs are entities that enforce patent rights primarily to generate licensing fees and litigation settlements rather than to manufacture products or conduct research themselves. Unlike traditional patent holders who practice their inventions by developing drugs or manufacturing medical devices, PAEs typically acquire patents from third parties and use them against operating companies. Critics argue that they exist primarily to exploit the patent system’s procedural costs and settlement dynamics to extract payments that have minimal relationship to the patent’s actual technological or commercial value.

This note argues that although the US patent system is designed to incentivize innovation, the rise of “patent trolls” poses unique risks to the biotechnology sector, where existing doctrines and patent quality mechanisms are insufficient to deter abusive enforcement specifically in biotechnology, where the combination of high R&D costs, long development timelines, regulatory complexity, and the scientific importance of foundational patents creates particular susceptibilities to opportunistic litigation.

Targeted reforms are needed to preserve the balance between protecting genuine innovation and preventing litigation abuses that threaten to tax the very innovation the patent system was designed to encourage.

II. Brief History of the World of Patent Eligibility in Biotechnology

**IIa. Diamond v. Chakrabarty, 447 U.S. 303 (1980) sets the foundation of patentability in biotechnology**

Diamond v. Chakrabarty is one of the most fundamental cases of biotechnology patent law, and dramatically expanded what types of inventions could be protected under US patent law, allowing for the existence of the modern biotechnology industry. In 1972, a genetic engineer working for General Electric, Dr. Anada Chakrabarty, was conducting pioneering research intended to support bioremediation of oil spills. The project involved genetically altering Pseudomonas bacterium to decompose hydrocarbons found in crude oils–a capability of the bacterium not found in nature. When the lab filed a patent for the breakthrough, the Patent Office rejected it on the ground that “living things are not patentable subject matter under” § 101 of the Patent Act, which governs the patentability of any new or useful inventions and discoveries.¹

In a narrow 5-4 majority, the Supreme Court reversed this, holding that the engineered living organisms are patent-eligible subject matter: “A live, human-made micro-organism is patentable subject matter under § 101. Respondent’s micro-organism constitutes a “manufacture” or “composition of matter” within that statute. Pp. 447 U. S. 308-318.”² The decision’s logic was straightforward: patent eligibility is based on human innovation and novelty of invention, not just whether or not the novel invention happens to be living. This doctrinal expansion, although simple, had immense practical significance in the biotechnology and life sciences fields, opening the door for the explosion of innovation across the industry. Before Chakabarty, the overwhelming consensus among life science professionals was that living organisms, especially microorganisms, were categorically excluded from patent protection. By clarifying that subject matter eligibility for patent protection hinges on human manipulation rather than nature, the stage had been set for extensive patenting of biological innovations.

IIb. Birth of the Modern “Biotech” Industry

In 1980, just a few months after the Chakabarty decision, the world’s first “biotech” company, Genetech, exploded onto the market in an industry-defining event, marking the birth of the modern biotech industry by proving that science-based startups with no immediate products could generate immense public interest, beginning the rush of venture capital investment and corresponding cascade of innovation and patenting. Genetech, founded by scientists from the University of California San Francisco and venture capitalists, went public with an astounding IPO of one million shares at $35 a share, ending its first hour on the market at $88.³

**IIc. Assoc. for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013) as a landmark eligibility clarification case**

Assoc. for Molecular Pathology v. Myriad Genetics, Inc. was a 2013 landmark case that represents a moment of clarity and realignment within the life sciences patent eligibility, further refining what is defined as a “product of nature” and making a doctrinal shift away from the more expansive interpretation endorsed by Chakrabarty and toward a more constrained understanding of patent-eligible subject matter § 101. The case arose after Myriad Genetics identified the precise location and sequence of two genes, BRCA 1 and BRCA 2, whose mutations are very strongly associated with increased breast and ovarian cancer risk. Following the discovery, Myriad obtained patents in which they claimed exclusive rights to both the synthetically created DNA (cDNA) and also the naturally occurring isolated segments of human DNA.

These patents effectively granted Myriad a complete monopoly over genetic testing for BRCA mutations, after which they were widely accused of price gouging by charging over $4,000 per test. This monopolistic behavior, combined with the prevention of other labs from offering tests or offering second opinions, prompted a response from an outraged coalition of researchers, physicians, and patients to challenge the validity of their patents. At its core, the dispute raised the very fundamental question: are human genes patentable?

In a unanimous decision, the Supreme Court drew a critical distinction between discovery and invention when it held that naturally occurring DNA sequences are not patentable, even when isolated from the human body; however, cDNA, which is synthetically created, remains patent-eligible. Justice Thomas, writing for the Court, emphasized that “separating that gene from its surrounding genetic material is not an act of invention,” and that if the court were to rule out that distinction, it “would be at odds with the very point of patents, which exist to promote creation.”⁴ Essentially, based on the informational content of the gene, isolation alone does not transform a natural phenomenon into a human-made invention.

While Myriad is often viewed as a victory for open science and patient access, its implications in patent litigation are slightly more complex and gray. By narrowing down what constitutes patent-eligible subject matter, the decision was intended to reduce overly broad claims on foundational biological materials. However, the post-Myriad landscape has not eliminated the same risks seen in the case associated with opportunistic patent enforcement. Instead, it may have been one of the baseline cases to shift those risks towards more complex and technically ambiguous claims, particularly in areas like synthetic biology, gene editing, and delivery platforms.

As the scope of clearly patent-eligible subject matter narrows, the value of strategically drafted, aggressive, and borderline-valid patents increases, creating new opportunities for entities that specialize in litigation rather than the pure goal of ‘creation’ through innovation, as Justice Thomas alluded to.

III. Defining the Current Patent Strategy in the “Biotechnology Battleground”

IIIa. IP as a Valuation Tool and Strategic Asset

The biotechnology and biopharmaceutical industries as a whole experience exceptionally high frequencies of patent battles compared to most other sectors. High research and development costs (often 40-50% of revenue) along with potential high rewards make securing and defending intellectual property absolutely critical to survival in this space.

In the biotechnology sector, patents function as core assets to underpin valuation and long-term strategic positioning. In alignment with this, investors in early-stage ventures in the life sciences view patent portfolios as a foundational balance sheet asset, rather than an exclusively legal tool, and often assess the IP portfolio as a key indicator of the company’s ability to defend its market position and ensure a return on investment. Empirical research demonstrates that the presence of patent protection significantly accelerates access to venture capital funding, including a 2023 study by the EPO and EUIPO, startups with both patents and trademarks are approximately 10.2 times more likely to secure early-stage funding than their peers without.⁵

In this vein, investors are often looking for broad patents covering compounds, novel formulations, manufacturing processes, and methods-of-use that create ‘defensive moats’ for the company to operate in. In essence, intellectual property– particularly patent portfolios–establish their value and utility as defensibility assets for future commercial profit and as a proxy for technological validity. Patents frequently constitute the most valuable (and sometimes only) tangible asset held by an early stage biotechnology company.⁶ As these firms often lack revenue streams, physical infrastructure, or marketable products, their intellectual property effectively becomes the foundation of their balance sheet. This dynamic is clearly reflected in the valuation outcomes: companies with more extensive patent portfolios consistently achieve higher valuations at both startup financing and IPO stages, suggesting an, even casual, direct correlation between IP ownership and perceived firm value.⁷

This clear financialization of patents reshapes their functional role within the ecosystem, and, rather than serving solely as innovation incentives, patents are more often than not applied as instruments of leverage: they are used to secure funding, negotiate strategic partnerships, and to possibly position the firm well for either an IPO or an acquisition by an established R&D powerhouse.

IIIb. Approaching patent strategy as a large biopharmaceutical

While intellectual property serves as a foundational asset for early-stage companies, it can play an equally critical and often more complex role within large biopharmaceutical and pharmaceutical companies. For these firms, patents are not just strategy tools, but also tools of protection for central components of competitive strategy, product release, product lifestyle management, and even market control.⁸

Large pharmaceutical companies typically construct extensive “patent thickets” around their successful therapeutics, which involves layering multiple patents to cover not only the actual active compound, but also the formulations, methods of use, delivery mechanisms, and more: this strategy expenses the effective period of market exclusivity beyond the life and scope of just one patent, delaying generic entry and maximizing revenue in blockbuster drugs coming out of extensive R&D pipelines. Concurrently, firms will aggressively enforce their patents through litigation to protect the current product and prevent competitors from entering adjacent spaces covered by the patent thicket.⁹

This environment produces a litigation and settlement landscape where patent disputes are frequent and economically significant, almost to the point of becoming a routine component of business strategy. These disputes, seemingly never-ending, often involve highly technical subject matter like biologics, gene therapies, and even delivery systems, making them costly and complex to adjudicate.

IIIc. Case Study: Lipid Nanoparticle Litigation Chronicles

One of the most illustrative modern patent disputes in biotechnology involves litigation over lipid nanoparticle (LNP) delivery systems, a foundational technology enabling mRNA therapeutic and vaccine delivery to systems within the human body. In 2022, Alnylam Pharmaceuticals filed a patent infringement lawsuit against Pfizer and Moderna, alleging that their COVID-19 vaccines unlawfully incorporated Alnylam’s patented LNP delivery technology. The patents covered specific biodegradable cationic lipid structures used to transport the nucleic acids into cells. The litigation quickly turned on issues of claim confusion rather than the broader questions of scientific innovation.¹⁰

In the case against Moderna, the U.S District Court for the District of Delaware adopted a narrow interpretation of the key claims–particularly a single definition: “the district court concluded that Alnylam had acted as lexicographer regarding the claim term “branched alkyl” in the following portion of the specification: Unless otherwise specified, the term[] “branched alkyl” . . . refer[s] to an alkyl . . . group in which one carbon atom in the group (1) is bound to at least three other carbon atoms and (2) is not a ring atom of a cyclic group.”¹¹

The Court concluded that Moderna’s vaccine did not infringe on the asserted patents. A Federal Appellate Court affirmed this judgment in 2025, holding that Alnylam’s own patent specification limited the scope of its claims. Following the adverse ruling, Alnylam was, however, able to ultimately reach a settlement, resolving the dispute and dismissing its claims.¹² Notably, the parties did not disclose the financial terms of the agreement. This lack of transparency is itself characteristic of high-stakes patent litigation, where confidential settlements often obscure the true economic impact of disputes.

Parallel litigation against Pfizer and BioNTech followed a similar trajectory. After a district court interpreted the asserted patents in a manner that excluded Pfizer’s vaccine from their scope, Alnylam voluntarily dismissed the claims, effectively conceding non-infringement under the court’s narrow construction.¹³

Nevertheless, litigation involving the same class of LNP technology provides a useful benchmark for digesting the scale of potential liability. In a separate dispute regarding infringement on lipid nanoparticle technologies, Moderna agreed to pay $2.25 billion to Genevant and Arbutus in 2026, resolving all U.S. and international patent and legal action and possibilities of future royalties to the firms. This figure–among the largest patent settlements in biotechnology–underscores the immense financial value attached to foundational platform technologies.¹⁴

Taken together, the Alnylam litigation demonstrates that even unsuccessful patent claims can carry significant economic consequences due to the high value of the underlying technologies and the cost of defending the infringement suits. More broadly, it illustrates how biotechnology patent disputes operate at the intersection of complexity and ambiguity around massive financial stakes. These conditions both incentivise aggressive enforcement by researching companies and create perfect conditions for litigation-focused entities to extract substantial settlements by leveraging uncertainty and cost asymmetries, even when the likelihood of ultimate success of a product on its own merits is limited.

IV. Patent Assertion Entities In Practice: Litigation Strategy

IVa. Defining a Litigation-Driven Business Model

The term “patent troll” has no formal statutory definition, but is widely used to describe patent assertion entities, which are organizations that acquire and enforce patents without engaging in the development, manufacturing, or commercialization of the underlying technology. Scholars and policymakers generally define PAEs by their business model rather than legal status: entities whose primary purpose is to monetize patents rather than innovate or participate in the market.¹⁵

Empirical research from as early as 2016 by the Federal Trade Commission provides one of the most comprehensive analyses of PAE behavior in the form of a report titled “Patent Assertion Entity Activity: An FTC Study”, which examines public and non-public data from 22 PAEs, 327 PAE affiliates, and more than 2100 holding entities.¹⁶ The report describes two major categories: “portfolio PAEs”, which acquire large patent portfolios and negotiate licensing deals, and “litigation PAEs”, which derive the majority of their revenue through infringement lawsuits rather than by negotiated licensing.¹⁷ These entities frequently file lawsuits before meaningful technology licensing discussions even occur, using litigation itself as a mechanism to generate profit through settlements.

Litigation PAEs accounted for approximately 96% of all patent infringement lawsuits in the study, yet generated only 20% of the total PAE revenue, which reflects their high-volume, low-value claims strategy. Moreover, 93% of licensing agreements entered into by litigation PAEs arose only after litigation was already initiated, which demonstrates clearly that lawsuits function as a primary method for extracting settlements, instead of a next step if negotiations fall through or there is a gross overstep of patent protection for an innovation.¹⁸

The FTC’s findings are also reinforced by additional analysis indicating that litigation-driven PAEs frequently pursue relatively small settlements (often below $300,000) that are nevertheless economically rational for defendants to pay given the high cost of continuing litigation. As a result, the PAE business model is best understood not as one aimed at vindicating patent rights in the traditional sense, but as one designed to leverage the procedural and financial dynamics of litigation itself.

Legislative testimony before Congress further highlights the operational tactics employed by PAEs. Hearings before the House Judiciary Committee and related subcommittees document widespread concern that PAEs send vague and often threatening demand letters to alleged infringers, sometimes with limited substantive analysis of actual infringement. These communications are frequently directed at small/medium-sized businesses, which are less equipped to evaluate or defend against complex patent claims.¹⁹

IVb. Exploiting cost asymmetries and settlement pressure

A very central feature of the predatory nature of PAE litigation is the, often clear, exploitation of cost asymmetries between the plaintiffs and defendants in the cases they bring forward. Patent litigation tends to be notoriously expensive, and defense costs against a suit can often reach into the hundreds of thousands.

For established research and development corporations, the cost of discovery and R&D is often astronomical, with pipelines for a single drug to go-to-market costing roughly between $1.3 billion and $2.8 billion with a timeline of 10-15 years. These figures include the immense cost of failed clinical trials, preclinical and translational research, regulatory approvals, etc, and, with that, only 1 in 10,000 compounds successfully reach the market to create a return on investment.²⁰ These figures for large pharmaceuticals are staggering; however, it is important to note that they are much more equipped to absorb R&D costs than early-stage startups pioneering new technologies and biological solutions, who are often also the targets of PAEs.

By contrast, PAEs, who do not manufacture products or engage in the R&D process, typically face significantly lower discovery burdens, which gives them a structural and financial advantage in litigation proceedings. This imbalance creates very powerful settlement incentives, and the FTC found that many PAE licensing demands fall below the expected cost of defending the lawsuit, which is a pattern that is consistent with what policymakers in the space describe as “nuisance litigation.” As a result, the defendants, especially with the investments they make into R&D, are more likely to choose to settle even when they may believe that the asserted patents are invalid or non-infringing, simply to avoid the financial and operational disruptions litigation would likely bring.

In this way, the structure of patent litigation itself becomes the mechanism for value extraction. The success of the PAE claims does not depend on the strength of the underlying patent, but rather on their ability to place economic pressure on the defendants.

V. Lessons from PAE Litigation in Other Sectors

Va. Quantifying Trends in PAE Litigation

Although biotechnology has not yet experienced the same volume of high-profile PAE litigation as sectors such as software and telecommunications, empirical evidence from these industries can provide some insight into how such entities operate at scale. One of the most comprehensive and influential sources of such data is the Stanford Non-Practicing Entity Litigation Dataset, developed by researchers at Stanford Law School and presented in Who’s Suing Us? Decoding Patent Plaintiffs since 2000 with the Stanford NPE Litigation Dataset by Shawn P. Miller and his coauthors.²¹

The Stanford dataset represents the first large-scale effort to systematically categorize patent plaintiffs across all U.S. patent litigation. It analyzes tens of thousands of cases and ultimately covers more than 60,000 patent lawsuits filed from 2000 to 2017. Most notably, the dataset classifies patent asserters into twelve distinct categories, including practicing entities and multiple subtypes of non-practicing entities of which PAEs form a central subset.²²

The categorization is significant because earlier databases regarding “patent trolls” were often limited by incomplete and anecdotal data. By contrast, the Stanford dataset provides a very systematic empirical foundation for evaluating how different types of patent holders behave in litigation. As the authors explain, the dataset enables researchers and policymakers to observe how patterns of patent enforcement have evolved over time, particularly in response to major legal developments in the space like the 2011 America Invents Act, which moved the U.S. from a “first-to-invent” system to a “first-to-file” system, aligning with international practices and adding post-grant review.²³

The dataset reveals a fundamental shift in the composition of patent litigation. Based on a random sample of 10,800 lawsuits filed from 2000 through 2015, licensing firms that acquire patents from third parties were responsible for less than 5% of distinct defendant‑plaintiff disputes in 2000. This number grew to account for more than 30% by the mid‑2010s, post-America Invents.²⁴

The figures paint a clear picture of PAE involvement in litigation expanding dramatically over the dataset’s timeframe, and the growth began well before the procedural reforms introduced by the America Invents Act. This would possibly suggest that the growth of PAEs reflects more structural incentives within the patent system rather than just procedural opportunism from the PAEs.

Additionally studies using the Stanford data have documented that PAE lawsuits tend to terminate much more quickly and settle more frequently than disputes brought about by practicing entities, consistent with the strategy described in section III of this paper of extracting early, “nuisance-value” settlements rather than fully pursuing long-term litigation on the patent’s own merits, as Alnylam and Genevent did in their respective LNP cases against Moderna. Specifically, non-practicing entity cases averaged 327 days to termination, compared to 443 days for practicing entity cases.²⁵

Vb. A Disclaimer on PAE Activity

The dataset also shows that PAEs are most active in technology sectors characterized by broad, interoperable, and modular technologies (like software or telecommunications) where patents can be asserted across many products and defendants. Although biotechnology litigation has historically been very concentrated on narrow, highly technical subject matter patents, the increasing centrality of platform technologies like gene editing systems or therapeutics delivery mechanisms in the life sciences raises the potential for similar patterns of broad enforcement if PAEs choose to enter the space en mass.

Vc. Case Study: VirnetX Inc. vs Apple

The long-running dispute between VirnetX Inc. and Apple provides one of the most prominent examples of PAE litigation in practice. VirnetX, widely characterized as a patent holding company that does not produce consumer products, asserted patents related to secure communications technology against Apple’s iconic features of FaceTime, iMessage, and VPN-on-demand. After over a decade of litigation (uncharacteristically long, but warranted for the payout) VirnetX secured multiple jury verdicts against Apple including a $302.4 million verdict related to FaceTime functionality and a later $502.8 million jury award tied to the VPN patent suite.²⁶ At various points, courts also imposed ongoing royalties on Apple products incorporating the accused technology, demonstrating how patent claims can scale across millions of devices.

However, the ultimate trajectory of this case underscores the importance and uncertainty of patent validity. In 2023, the Federal Circuit Court of Appeals affirmed decisions invalidating key VirnetX patents through review proceedings known as inter partes review, effectively overturning the verdict, citing “The parties in this case agreed that if we affirmed the Board’s finding of unpatentability, then the Patent and Trademark Office would be obligated to cancel the claims of both patents and, therefore, VirnetX would no longer have a legally cognizable cause of action against Apple.”²⁷ The Supreme Court later declined to review the case, leaving the invalidation intact and eliminating Apple’s liability for that award.²⁸

This litigation illustrates several defining characteristics of PAE enforcement. For one, it demonstrates how non-practicing entities can target highly successful products using patents that cover relatively narrow technological components. Moreover, it seriously highlights the potential for extraordinary damages exposure, even where the patented technology represents only a small portion of a complex product. Third, it reveals the central role of patent validity challenges in reshaping litigation outcomes after substantial jury awards have already been issued.

The litigation also provides a very clear picture of how defendants can push back against PAE claims, though focusing their challenges on patent validity. One of the more significant developments of modern patent litigation is the increasing use of inter partes review proceedings, which allow third parties to challenge the validity of issued patents.²⁹ In this case, Apple and other entities were able to successfully leverage this review process to invalidate the patents underlying the infringement claims.³⁰ At the same time, one must also acknowledge the limitations of this defense mechanism: patent validity challenges typically only start after litigation has already begun, meaning the defendants are already starting to incur substantial legal costs before obtaining relief and investing time into completing the proceedings, which can also lead to more settlement pressure if the PAE is pursuing parallel litigation.

VI. Patent Validity & Quality: Defending against opportunistic litigation

VIa. Quantitative Trends in PAE Litigation

While the prospect of rampant, abusive patent assertion sounds disheartening, the key structural limitation to this misuse of the system lies in the substantive requirements for patent validity and quality. Even if a PAE initiates litigation, defendants have multiple legal doctrines and judicially developed standards they can use to challenge the enforceability of asserted patents. Two landmark cases – Merck KGaA v. Integra Lifesciences I, Ltd. and Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co – serve as hopeful examples of how courts upheld and strengthened substantive patent law requirements in ways that constrain overly broad and truly indefensible patent claims.

VIb. Merck KGaA v. Integra Lifesciences I, Ltd.

In Merck v. Integra, Merck funded research involving patented peptides at Scripps Research Institute and was sued for infringement by Integra when they identified a potential drug candidate. The Supreme Court clarified the scope of the statutory safe harbor provision in 35 U.S.C § 271(e)(1), holding that the use of patented compounds in preclinical studies is exempt from infringement as long as there is a reasonable basis for believing that the experiments will yield information relevant to an Investigational New Drug application or New Drug Application with the FDA. The court emphasized that the statute’s text is broad and protects all uses “reasonably related” to the development and submission of regulatory information, materially lowering the risk that research activities will be classified as actionable infringement. Justice Scalia delivered the opinion, citing that “It is not ‘an act of [patent] infringement to … use … or import into the United States a patented invention … solely for uses reasonably related to the development and submission of information under a Federal law which regulates the … use … of drugs.’ The Federal Food, Drug, and Cosmetic Act of 1938 (FDCA) is such a law.”³¹

This safe harbor provision is particularly significant in biotechnology, as research often requires years of preclinical and translational studies, and the decision has positive implications for defending against opportunistic patent assertion in the space: it shelters real research from infringement liability and raises the bar for PAEs to assert patents against ordinary scientific research activities. A defendant can argue that its use of a patented invention falls under §271(e)(1) when the activity is reasonably related to regulatory filings, even if the experiments happen before commercialization. Because PAEs themselves are not engaging in research or regulatory filings, applying this precedent may push the speculative infringement claims outside the scope of punishable conduct.

VIc. Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co

A very different but equally important constraint on patent quality comes from the Federal Circuit’s decision on Ariad Pharmaceuticals, Inc. v. Eli Lilly, which reaffirmed and further clarified the written description requirement in patents under 35 U.S.C. § 112. The case centered around Ariad Pharmaceuticals, who held a patent that covered methods for regulating a protein determined to be key in the body’s immune response, and sued Eli Lilly, alleging that two of their drugs infringed on the patent. A jury in Massachusetts initially found the patent valid and infringed upon, awarding Ariad $65 million back in royalties for this.³²

When appealed, the Federal Circuit held that 35 U.S.C. § 112 contains a requirement separate from enablement, meaning that a patent must clearly describe what the invention is and show that the inventor actually possessed the claimed invention as of the filing date. The decision emphasized that to satisfy the written description requirement of the patent, the description actually has to “reasonably convey” that the inventor had possession of the claimed subject matter: “the goal is to get the right balance, and the written description doctrine does so by giving the incentive to actual invention and not “attempt[s] to preempt the future before it has arrived.”³³ This standard ensures that claims do not reach beyond what the patentee actually invented and disclosed at the time of filing, curbing excessively broad or speculative claims that cannot be justified by the disclosure.

In Araid, the court invalidated claims because the specification failed to demonstrate that the inventors had actually invented the broad biological mechanisms claimed, even though the patent arguably enabled their practice with the mechanism. In essence, the decision showed the necessity of a robust written description, especially in biology, where patents often cover complex molecular mechanisms and foundational technologies.

For defendants facing PAE litigation, Ariad can offer a powerful tool of challenging patents that lack precise, concrete disclosure under the written description requirement. Because PAEs frequently rely on acquiring broad, ambiguous patents to maximize their litigation leverage, they could be more vulnerable to invalidation under a very strict written description comparison/analysis.

VId. Synthesizing doctrinal limits to fight opportunistic enforcement

Together, Integra and Ariad illustrate how substantive patent law can impose helpful and meaningful limits on predatory assertion of low-quality and overly broad patents, often the very character of opportunistic PAE litigation.

While procedural reforms are often proposed to combat abusive litigation, these decisions show that the judiciary has already started to develop doctrinal mechanisms that can restrict the impact of PAEs, especially in a life sciences context where regulatory and disclosure requirements are so stringent. Unlike procedural defenses, which can be applied only after litigation begins, substantive challenges go directly to the core of what actually constitutes a valid patent. Defendants can bring these doctrines early in litigation through motions to dismiss or summary judgment to avoid protracted discovery and settlement pressure that PAEs are so fond of. This is particularly relevant in biotechnology, where defendants often cannot afford the high cost of full litigation and may otherwise be incentivized to settle superfluous claims.

VII. Conclusion

The U.S. patent system, at its very core, was designed to promote American innovation and grant investors temporary monopolies in exchange for their public disclosure of inventions. In biopharma and biotechnology, developing a single therapeutic can take over a decade and cost well over a billion dollars, so this incentive structure is absolutely essential in encouraging investment and advancing modern science.

However, the rise of PAEs threatens to distort this very original bargain. Empirical evidence shows that PAEs have become a major presence in U.S. patent litigation, with enforcement activities rising before reforms and starting to account for substantial shares of disputes across other sectors. While biotechnology has not yet seen the same volume of PAE activity as its software-based peers, the field is ripe and the structural conditions that enabled their rise (high-value platform-style technologies, complex claims, and costly litigation processes) exist and are becoming increasingly present. Cases like the LNP litigation saga involving Moderna serve as a stark example of the impact of high-stakes patent disputes over delivery platforms and highlight how enforcement dynamics can impose significant economic burdens even if patents are ultimately invalid or narrowly interpreted. Substantive legal doctrines like the §271(e)(1) for innovation safe harbor and the 35 U.S.C. §112 for the written description requirement provide important defenses against abusive assertions.

Nonetheless, targeted reforms are needed to ensure that the patent system continues to foster actual innovation rather than serving as a vehicle for opportunistic litigation. Ultimately, the promise of the patent system really depends on its continued alignment with the evolving realities of technology development. By addressing the unique vulnerabilities presented by PAEs in biotechnology, policymakers can help ensure that the patent system in the life sciences remains a tool for discovery and bringing transformative therapies to patients, rather than a metaphorical minefield of litigation risk that drains resources from the research it was designed to encourage.

Edited by Annie Cayer and Emma Morgan

About the Author

Anna Pociu is a junior at Northeastern University, majoring in Biochemistry with a minor in Business Administration. She is currently a Digital Writer for the Northeastern University Undergraduate Law Review and previously served as a Staff Writer for the print edition. As a Staff Writer, she published a research note titled The Hidden Research Regulator: How Federal Funding Shapes Academic Freedom, where she explores the legal doctrine and current policy directives building to the ability of federal funding and associated political motives to latently regulate academic freedom, institutional directions, and, by extension, American innovation. Currently, she is drafting a note on the rise of patent assertion entities and implications for innovation in biotechnology.

Anna’s legal interests center around intellectual property law, specifically patent litigation and prosecution, where she is passionate about exploring protections for innovation within the pharmaceuticals and biotechnology sectors. She previously completed a Process Development co-op with Allonnia, an environmental biotechnology spin-out of Ginkgo Bioworks. This summer, she is excited to dive into the pharmaceutical world at Alnylam Pharmaceuticals, where she will join the R&D team exploring lipid nanoparticle research.

Outside of academics and research, Anna can be found running on the Charles River Greenway (training for her next half-marathon), exploring yoga studios around Boston, museum hopping, and traveling as much as possible.